Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

December 15, 2015 updated by: SIFI SpA

Evaluation of Ocular Flora in Patients Undergoing Cataract Surgery. An Observational Study

The purpose of the present study is to elucidate the spectrum of ocular flora and their antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

A conjunctival and palpebral swab will executed at least 14 days before routine cataract surgery. Isolates will be identified using standard microbiological protocols. In vitro susceptibility will be determined using a breakpoint minimal inhibitory concentrations. In case of positivity, the swab will be repeated the day of surgery. Topical antibiotic may be used in case of positivity at the discretion of the surgeon. Descriptive statistics will be calculated.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95100
        • Casa di Cura Di Stefano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing routine cataract surgery

Description

Inclusion Criteria:

  • Patients scheduled for cataract surgery
  • Age > 18 years
  • Any gender and race
  • Willing to sign informed consent

Exclusion Criteria:

  • Any antibiotics within 3 months
  • Any ocular infection within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
single group
Patients undergone cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Culture in Subjects Scheduled for Cataract Surgery
Time Frame: At least 14 days before surgery
Number of participants with positive culture at the screening visit
At least 14 days before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic Susceptibility
Time Frame: At least 14 days before surgery
Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.
At least 14 days before surgery
Eradication Rate
Time Frame: Day of surgery
Number of participants having positive culture at the screening visit with bacterial eradication before surgery
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SIFI SpA

Investigators

  • Principal Investigator: Marcello Santocono, MD, Casa Di Cura Di Stefano Catania (Italy)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

December 15, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 041SI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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